BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 15882809 · Received November 29, 2022

    Report

    Report Number
    2124215-2022-49466
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    November 2, 2022
    Report Date
    November 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: PUBLICATION DATE OF 02NOV2022 USED AS EVENT DATE IS UNKNOWN. VUKOMANOVIC, D. ET AL. (2022). MASSIVE DEVICE-RELATED THROMBUS AFTER LAA OCCLUSION INTRAOPERATIVE INSIGHTS INTO MECHANISM. JOURNALS OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOLUME 4 (ISSUE 21), 1409-1413.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 27MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THE PATIENT WAS DISCHARGED ON WARFARIN AND ASPIRIN. AT A ROUTINE FOLLOW UP EXAMINATION TWO (2) MONTHS POST INDEX PROCEDURE, THE PATIENT WAS TRANSITIONED TO ASPIRIN AND CLOPIDOGREL. DURING A ROUTINE FOLLOW UP EXAMINATION ONE (1) YEAR POST INDEX PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A NON-MOBILE THROMBUS MEASURING 2.0CM BY 2.0CM ON THE SURFACE OF THE CLOSURE DEVICE. THE PATIENT WAS PRESCRIBED WARFARIN IN RESPONSE TO THE THROMBUS. SIX (6) MONTHS AFTER THE DISCOVERY OF THE THROMBUS, TEE SHOWED THE THROMBUS PERSISTED AND HAD NOT DECREASED IN SIZE. WARFARIN WAS DISCONTINUED AND DABIGATRAN, TWICE DAILY, WAS INITIATED. NINE (9) MONTHS POST DISCOVERY OF THE THROMBUS IMAGING REVEALED THE THROMBUS HAS SIGNIFICANTLY DECREASED IN SIZE. THE PATIENT EXPERIENCED A GASTROINTESTINAL BLEED WHICH REQUIRED A BLOOD TRANSFUSION. DUE TO THE NEED FOR A BLOOD TRANSFUSION, DABIGATRAN WAS DISCONTINUED, AND ASPIRIN WAS INITIATED. THREE (3) YEARS POST IMPLANTATION PROCEDURE AND ONE (1) YEAR FOLLOWING DISCONTINUATION OF DABIGATRAN, TEE REVEALED A MOBILE THROMBUS MEASURING 3.5CM BY 2.2CM ON THE SURFACE OF THE CLOSURE DEVICE. THE THROMBUS AND CLOSURE DEVICE WERE SURGICALLY REMOVED AND THE LAA WAS SURGICALLY RESECTED. THE CENTRAL SCREW HUB OF THE CLOSURE DEVICE WAS OBSERVED TO NOT HAVE ENDOTHELIALIZED. THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729199 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention